Albireo Pharma, Inc. (ALBO)
Albireo Pharma is a commercial-stage biopharmaceutical company focused on developing and commercializing novel bile acid modulators. Their lead product, Bylvay, addresses rare pediatric liver diseases, offering a significant advancement in treatment options.
Company Overview
Albireo Pharma pioneers treatments for rare pediatric liver diseases, focusing on novel bile acid modulators like Bylvay, which boasts a 96.7% gross margin and addresses unmet needs in orphan pediatric liver diseases, positioning the company for significant growth in a specialized market.
Investment Thesis
Albireo Pharma presents a compelling investment opportunity due to its focus on rare pediatric liver diseases and its commercial-stage product, Bylvay, which addresses a significant unmet need. The company's high gross margin of 96.7% indicates strong pricing power and potential for profitability as sales scale. Ongoing Phase III clinical trials for Bylvay in biliary atresia and Alagille syndrome represent significant growth catalysts, expanding the addressable market and revenue potential. Furthermore, the development of A3907 and A2342 for adult liver diseases provides long-term growth opportunities. With a market capitalization of $0.92 billion, Albireo offers an attractive entry point for investors seeking exposure to the high-growth orphan drug market.
Key Highlights
- Bylvay approved for the treatment of progressive familial intrahepatic cholestasis (PFIC), addressing a critical unmet need in rare pediatric liver diseases.
- Gross margin of 96.7% demonstrates strong pricing power and potential for high profitability.
- Phase III clinical trials underway for Bylvay in biliary atresia and Alagille syndrome, expanding the addressable market.
- A3907 in Phase I clinical trials for adult liver diseases, providing long-term growth potential.
- Market capitalization of $0.92 billion presents an attractive valuation relative to growth prospects in the orphan drug market.
Competitors
Strengths
- Commercial-stage product (Bylvay) with established revenue stream.
- Focus on rare pediatric liver diseases with high unmet needs.
- Strong gross margin (96.7%).
- Pipeline of product candidates in Phase III clinical trials.
Weaknesses
- Reliance on a limited number of products.
- Negative P/E ratio (-5.61) and profit margin (-373.0%).
- Dependence on regulatory approvals for pipeline products.
- Relatively small size compared to larger pharmaceutical companies.
Catalysts
- Upcoming: Phase III clinical trial results for Bylvay in biliary atresia (expected within the next 12-18 months).
- Upcoming: Phase III clinical trial results for Bylvay in Alagille syndrome (expected within the next 12-18 months).
- Upcoming: Initiation of Phase II clinical trials for A3907 in adult liver diseases (expected within the next 12 months).
- Ongoing: Continued commercialization and market penetration of Bylvay.
- Ongoing: Potential for new strategic partnerships and collaborations.
Risks
- Potential: Regulatory setbacks or delays in clinical trials.
- Potential: Competition from other companies developing therapies for liver diseases.
- Potential: Pricing pressure from payers.
- Potential: Dependence on key personnel.
- Ongoing: Negative profitability and need for additional financing.
Growth Opportunities
- Biliary Atresia Expansion: Bylvay is currently in Phase III clinical trials for biliary atresia, a rare and life-threatening liver disease in infants. Positive trial results and subsequent regulatory approval would significantly expand Bylvay's addressable market. The market for biliary atresia treatments is estimated to be substantial, given the lack of effective non-surgical options. Timeline: Potential approval within the next 2-3 years.
- Alagille Syndrome Expansion: Albireo is also conducting Phase III clinical trials for Bylvay in Alagille syndrome, another rare genetic disorder affecting the liver, heart, and other organs. Approval in this indication would further diversify Bylvay's revenue streams and solidify its position as a leading treatment for cholestatic liver diseases. Market size is significant given the limited treatment options. Timeline: Potential approval within the next 2-3 years.
- A3907 Development: Albireo's A3907, currently in Phase I clinical trials, targets adult liver diseases. Successful development and commercialization of A3907 would expand Albireo's product portfolio beyond pediatric indications and tap into a larger market for liver disease treatments. The adult liver disease market is substantial, encompassing conditions such as non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). Timeline: Phase II trials expected to begin within the next 1-2 years.
- Geographic Expansion: Albireo has the opportunity to expand the geographic reach of Bylvay and other pipeline products. Currently, Bylvay is approved in the United States and Europe. Expanding into other markets, such as Asia and Latin America, would drive revenue growth and increase patient access to these important therapies. The global market for liver disease treatments is growing, driven by increasing prevalence of liver diseases and rising healthcare expenditure. Timeline: Ongoing, with potential for expansion into new markets within the next 1-3 years.
- Elobixibat Commercialization: Albireo has a license agreement with EA Pharma Co., Ltd. for the development and commercialization of elobixibat. Successful commercialization of elobixibat for chronic constipation and other functional diseases would generate royalty revenue for Albireo and contribute to overall financial performance. The market for constipation treatments is large and growing, driven by aging populations and lifestyle factors. Timeline: Ongoing, with potential for increased royalty revenue within the next 1-2 years.
Opportunities
- Expansion of Bylvay into biliary atresia and Alagille syndrome.
- Development of A3907 for adult liver diseases.
- Geographic expansion into new markets.
- Potential for strategic partnerships and collaborations.
Threats
- Competition from other companies developing therapies for liver diseases.
- Regulatory setbacks or delays in clinical trials.
- Pricing pressure from payers.
- Potential for generic competition upon patent expiration.
Competitive Advantages
- Proprietary bile acid modulator technology.
- Orphan drug designation for Bylvay, providing market exclusivity.
- Strong intellectual property protection for key products.
- Established relationships with key opinion leaders in pediatric liver diseases.
About
Albireo Pharma, Inc. is a commercial-stage biopharmaceutical company committed to transforming the lives of patients with rare liver diseases. The company was founded with a focus on developing and commercializing novel bile acid modulators, addressing significant unmet needs in orphan pediatric liver diseases and other liver or gastrointestinal disorders. Albireo's lead product, Bylvay (odevixibat), is approved for the treatment of progressive familial intrahepatic cholestasis (PFIC), a rare and devastating genetic disorder affecting young children. Bylvay represents a significant advancement in the treatment of PFIC, offering a non-surgical option for patients. Beyond Bylvay, Albireo is advancing a pipeline of innovative therapies, including programs in Phase III clinical trials for biliary atresia and Alagille syndrome, further expanding the potential reach of their treatments. The company is also developing A3907, currently in Phase I clinical trials for adult liver diseases, and A2342, a preclinical candidate targeting adult viral and liver diseases. Albireo has a strategic license agreement with EA Pharma Co., Ltd. for the development and commercialization of elobixibat, further demonstrating their commitment to addressing a range of liver and gastrointestinal conditions. Headquartered in Boston, Massachusetts, Albireo is dedicated to improving the lives of patients and families affected by rare liver diseases through innovative science and a patient-centric approach.
What They Do
- Develop and commercialize novel bile acid modulators.
- Offer Bylvay for the treatment of progressive familial intrahepatic cholestasis (PFIC).
- Conduct Phase III clinical trials for Bylvay in biliary atresia.
- Conduct Phase III clinical trials for Bylvay in Alagille syndrome.
- Develop A3907 for the treatment of adult liver diseases (Phase I clinical trial).
- Develop A2342 as a preclinical candidate for adult viral and liver diseases.
- License elobixibat for the treatment of chronic constipation.
Business Model
- Develop and commercialize proprietary pharmaceutical products.
- Generate revenue through direct sales of Bylvay.
- Out-license certain products for development and commercialization in specific territories.
- Receive royalty payments on sales of licensed products.
Industry Context
Albireo Pharma operates in the biotechnology industry, specifically targeting the orphan drug market for rare pediatric liver diseases. This market is characterized by high unmet needs, limited treatment options, and premium pricing. The industry is driven by innovation, regulatory incentives for orphan drug development, and increasing awareness of rare diseases. Albireo's focus on bile acid modulators positions it within a specialized segment of the liver disease market. Competitors in this space include companies developing therapies for liver diseases, such as Cymabay Therapeutics (CBIO), but Albireo's focus on rare pediatric conditions provides a degree of differentiation.
Key Customers
- Pediatric patients with progressive familial intrahepatic cholestasis (PFIC).
- Pediatric patients with biliary atresia (potential future market).
- Pediatric patients with Alagille syndrome (potential future market).
- Adult patients with liver diseases (potential future market).
Financials
Chart & Info
Price Chart
Albireo Pharma, Inc. (ALBO) stock price: $44.15 (+0.00, +0.00%)
Why Bull
- •Recent insider buying suggests confidence in Albireo's future prospects, indicating that those closest to the company believe in its growth potential.
- •Positive community sentiment has emerged around Albireo's pipeline developments, particularly regarding treatments for rare liver diseases, which could enhance market position.
- •Analysts have noted increasing interest in Albireo's innovative therapies, reflecting a growing recognition of its unique offerings in the biotech space.
- •Recent collaborations and partnerships have bolstered Albireo's credibility, enhancing investor confidence in its ability to execute on strategic initiatives.
Why Bear
- •Concerns about regulatory hurdles for Albireo's drug approvals have surfaced, creating uncertainty among investors regarding the timeline for market entry.
- •Community sentiment has shown volatility, with some investors expressing skepticism about the sustainability of Albireo's recent advancements and their commercial viability.
- •Recent market developments have highlighted competitive pressures in the biotech sector, raising questions about Albireo's ability to maintain its edge.
- •The company's financial health remains a concern for some, with ongoing discussions about funding and cash flow management potentially affecting growth initiatives.
Latest News
No recent news available for ALBO.
Technical Analysis
Rationale
AI-generated technical analysis for ALBO including trend direction, momentum, and pattern recognition.
What to Watch
Key support and resistance levels, volume signals, and upcoming events.
Risk Management
Position sizing, stop-loss levels, and risk-reward assessment.
Community
Discussion
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Sentiment
Community sentiment and discussion activity for ALBO.
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Current price: $44.15
Analyst Consensus
Consensus Rating
Aggregated Buy/Hold/Sell recommendations from Benzinga, Yahoo Finance, and Finnhub for ALBO.
Price Targets
Wall Street price target analysis for ALBO.
Insider Flow (30d)
No insider trades in the last 30 days.
MoonshotScore
Score Factors
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Revenue Growth 5/100
Revenue growth data is currently unavailable for this company.
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Gross Margin 5/100
Gross margin data is currently unavailable for this company.
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Operating Leverage 4/100
Limited operating leverage due to slower revenue growth, keeping profit scaling constrained.
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Cash Runway 5/100
Cash position data is currently unavailable for this company.
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R&D Intensity 5/100
R&D spending data is currently unavailable for this company.
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Insider Activity 6/100
No significant insider buying or selling recently, which is neutral for the stock outlook.
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Short Interest 5/100
Float and volume data unavailable for liquidity analysis.
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Price Momentum 0/100
No bullish technical signals detected. The stock lacks upward price momentum currently.
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News Sentiment 5/100
No sentiment data available
What does this score mean?
The MoonshotScore rates ALBO's growth potential on a scale of 0-100 across multiple factors including innovation, market disruption, financial health, and momentum.
Frequently Asked Questions
What does Albireo Pharma, Inc. do?
Albireo Pharma is a commercial-stage biopharmaceutical company focused on developing and commercializing novel bile acid modulators to treat rare pediatric liver diseases and other liver or gastrointestinal diseases. Their primary product, Bylvay, is approved for treating progressive familial intrahepatic cholestasis (PFIC). The company is also developing Bylvay for other indications like biliary atresia and Alagille syndrome, and has early-stage programs targeting adult liver diseases. Albireo operates by developing proprietary drugs, securing regulatory approvals, and commercializing these therapies to address unmet needs in specialized markets.
Is ALBO stock a good buy?
ALBO stock presents a mixed investment profile. The company's focus on rare diseases and high gross margins (96.7%) are attractive. Positive results from ongoing Phase III trials for Bylvay could significantly boost its market value. However, the negative P/E ratio (-5.61) and profit margin (-373.0%) indicate current unprofitability, requiring careful consideration of financial risks. Investors should weigh the growth potential against the company's current financial performance and the inherent risks of pharmaceutical development before investing.
What are the main risks for ALBO?
Albireo Pharma faces several key risks. Clinical trial failures or regulatory delays could significantly impact its pipeline and future revenue. Competition from other companies developing liver disease therapies poses a threat to market share. Pricing pressures from healthcare payers could erode profitability. The company's current unprofitability and reliance on future financing also present financial risks. Additionally, the company is dependent on key personnel, and their loss could disrupt operations and strategic direction.
Is ALBO a good stock to buy?
Whether ALBO is a good investment depends on your financial goals, risk tolerance, and investment horizon. Key factors to evaluate include the company's revenue growth trajectory, profit margins, debt-to-equity ratio, competitive moat, and valuation multiples (P/E, P/S, EV/EBITDA) relative to industry peers. Our AI-generated Investment Thesis and SWOT analysis on this page provide a data-driven starting point. Always do your own research and consider consulting a financial advisor before making investment decisions.
What is the ALBO MoonshotScore?
The MoonshotScore for ALBO is an AI-powered rating from 0 to 100 that evaluates a stock across four dimensions: growth potential (revenue and earnings trajectory), financial health (balance sheet strength, cash flow), market momentum (price trends, volume patterns, institutional flows), and risk factors (volatility, debt levels, sector headwinds). Scores above 70 indicate strong potential, 50-70 moderate, and below 50 suggests caution. The score is recalculated daily using the latest financial data and market signals.
How often is ALBO data updated?
ALBO stock prices are updated in real-time during U.S. market hours (9:30 AM - 4:00 PM ET, Monday through Friday). After-hours and pre-market prices are also tracked. Company fundamentals (earnings, revenue, balance sheet) are refreshed when new quarterly or annual reports are filed. Analyst ratings, price targets, and AI-generated insights are updated daily. Breaking news related to ALBO is aggregated continuously from premium financial news sources throughout the day.
What are the growth catalysts for ALBO?
Growth catalysts for Albireo Pharma, Inc. (ALBO) can include several categories: product catalysts (new launches, FDA approvals, patent grants), financial catalysts (earnings beats, margin expansion, share buybacks), strategic catalysts (acquisitions, partnerships, market expansion into new regions), and macro catalysts (favorable regulation, industry tailwinds, secular growth trends). Our AI analyzes Albireo Pharma, Inc.'s specific catalysts using earnings transcripts, SEC filings, and news sentiment to identify the most impactful near-term and long-term drivers.
Who are ALBO's main competitors?
Albireo Pharma, Inc. (ALBO) competes with companies in its industry that target similar customers, markets, or product categories. Competitor analysis involves comparing key metrics: market share, revenue growth rates, profit margins, R&D spending, and valuation multiples. Understanding competitive positioning helps investors assess whether ALBO has a sustainable competitive advantage (moat) through brand strength, network effects, cost leadership, or switching costs. Our Competitors section provides a side-by-side comparison with relevant peers.
What do analysts say about ALBO?
Wall Street analyst coverage for ALBO includes consensus ratings (buy, hold, or sell), 12-month price targets, and earnings estimates. Analyst opinions are aggregated from major investment banks and research firms. Key metrics to watch include the consensus price target (average, high, and low estimates), the number of analysts covering the stock, any recent rating changes (upgrades or downgrades), and how actual earnings compare to analyst estimates (beat or miss history). Our platform aggregates these from multiple data providers for a comprehensive view.
What is ALBO's market cap?
Market capitalization (market cap) for ALBO is calculated by multiplying the current share price by the total number of outstanding shares. It represents the market's total valuation of the company. Stocks are typically categorized as mega-cap ($200B+), large-cap ($10B-$200B), mid-cap ($2B-$10B), small-cap ($300M-$2B), or micro-cap (under $300M). Market cap influences index inclusion, institutional ownership eligibility, and risk profile. Our Key Statistics section shows ALBO's current market cap alongside enterprise value and other valuation metrics.
How has ALBO stock performed recently?
ALBO's recent stock performance can be evaluated across multiple timeframes: daily price changes, week-over-week momentum, monthly trends, and year-to-date returns. Important performance indicators include the stock's 52-week high and low, moving averages (50-day and 200-day SMA), relative strength index (RSI), and volume trends. Comparing ALBO's performance against its sector index and the S&P 500 provides context on whether it is outperforming or underperforming the broader market.
What are the risks of investing in ALBO?
Key risk categories for ALBO include: market risk (overall market downturns affecting stock prices), company-specific risk (management changes, product failures, competitive threats), financial risk (high debt levels, cash burn, dilution from stock issuance), regulatory risk (government policy changes, lawsuits, compliance issues), and macroeconomic risk (interest rate changes, inflation, currency fluctuations). Beta measures ALBO's volatility relative to the market - a beta above 1.0 means higher volatility than the S&P 500. Our AI-generated risk assessment identifies the most relevant risk factors for this specific stock.
Are insiders buying or selling ALBO?
Insider trading activity for ALBO tracks purchases and sales by company executives, directors, and major shareholders (10%+ owners) as reported in SEC Form 4 filings. Insider buying is generally considered a bullish signal because insiders have the deepest knowledge of company operations, while selling may have various motivations (diversification, tax planning, pre-planned 10b5-1 trading plans). Key metrics include the buy-to-sell ratio, total dollar value of insider transactions, and whether multiple insiders are trading in the same direction. Our Insider Flow tab shows recent transactions with dates and dollar amounts.
Is ALBO a good stock for beginners?
Albireo Pharma, Inc. (ALBO) can be suitable for beginner investors depending on several factors. Look at the MoonshotScore on this page for an overall AI-powered assessment of growth potential and risk. Beginners should also check the company's market cap (larger companies tend to be less volatile), gross margin (higher margins mean stronger business fundamentals), and cash position (healthy cash reduces bankruptcy risk). Always start with a small position size and never invest money you cannot afford to lose.
How risky is ALBO for first-time investors?
Every stock carries risk, including Albireo Pharma, Inc. (ALBO). First-time investors should review the Risk Factors section on this page for company-specific risks. Key risk indicators include price volatility (check the chart for daily swings), insider selling activity (see Insider Flow tab), and cash runway (see MoonshotScore breakdown). A diversified portfolio with an index fund like the S&P 500 as a core holding is generally recommended before adding individual stocks like ALBO.
Disclaimer: This content is for informational purposes only and does not constitute investment advice. Always do your own research and consult a financial advisor.
Data provided for informational purposes only.
- Financial data may be subject to change.
- Clinical trial outcomes are inherently uncertain.
- Market conditions and competitive landscape may evolve.